Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates

NCT00555932 | Completed

• 1 other identifier: 1000010745
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Our overall aim is to examine if ultrasound is as accurate as MRI and/or CT in the evaluation of dural venous sinuses. We hypothesize that sonography will be accurate (accuracy \>80%) for diagnosing specific anatomic findings of dural venous sinuses.

Conditions

Intracranial Thrombosis

Keywords

Intracranial Thrombosis; Cerebral Sinovenous Thrombosis; Pediatrics; Cranial Ultrasound

Outcome Measures

Primary Outcomes (1)

• To prospectively evaluate the feasibility of visualization of normal dural venous sinuses, their patency, and normal variations with ultrasound in newborn children (preterm & term), using cross sectional imaging (MRI and/or CT) as reference standards.

  Within 10 hours of the MRI scan

Secondary Outcomes (1)

• The ability of doppler ultrasound to evaluate flow velocities in all dural venous sinuses that will be evaluated in this study.

  Within 10 hours of MRI

Study Arms (1)

1

ACTIVE COMPARATOR

The research head ultrasound (HUS) will be performed at the bedside in the Neonatal Unit. The ultrasound examination will be performed within 10 hours time window of the MR and or CT study.

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

All the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit.

1

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All neonates (up to 28 days old) and preterm infants, hospitalized at HSC who need clinically indicated brain MR and MRV as part of their diagnostic workup. Clinical indications for MR could include birth asphyxia, seizures, irritability, lethargy, abnormal neurological examination, etc.
• Neonates and preterm infants \& who are clinically considered stable to undergo the ultrasound study. This will be determined at the bedside by the neonatology team in attendance.
• Where consent is available from parents.
• Only neonates and preterm infants who have undergone a technically adequate MRI study which includes vascular MR venography sequences or CT with contrast will be included. Assessments for technically adequacy will be made by the technologist or the supervising radiologist, as per clinical protocols currently used in the department of diagnostic imaging. This will be determined by referring to notes made on the request form and also by direct communication between the supervising radiologist and team members obtaining consent.

You may not qualify if:

• Vital signs will be monitored in the usual manner by the nurses in attendance in the neonatal unit. If the neonate is unstable, an ultrasound study will not be done.
• If after starting the ultrasound, any signs of instability are noted during the study, the ultrasound study will discontinued.
• If consent from parent or guardian is not available, the research ultrasound study will not be done.
• If the ultrasound cannot be done within a 10 hours window of the CT or MR study (due to technical problems with machine or skilled personnel not being available).
• Neonates \& preterm infants who have undergone technically inadequate MR and/or CT will not be included. Such technical inadequacy will be determined by referring to notes made by the technologist on the request form and by direct communication with the supervising radiologist.
• Neonates \& preterm infants undergoing repeat CT and/or MRs will be excluded from the study.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Links

• Link to final publication abstract

MeSH Terms

Conditions

Intracranial Thrombosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Manohar Shroff

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Diagnostic Imaging, Pediatric Neuroradiologist

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 20, 2015

Record last verified: 2008-05

Locations

CA (1)